Quality Control Lead, BASE Facility

• Australian Institute for Bioengineering and Nanotechnology (AIBN)

• New opportunity for a Quality Control Lead at BASE Clinical Lab

• Collaborate with world class researchers in state-of-the-art facilities

• Be part of an organisation with a meaningful purpose and impact

• Based at our vibrant St Lucia Campus

About UQ

As part of the UQ community, you’ll have the opportunity to work alongside the brightest minds, who have joined us from all over the world.

Everyone here has a role to play. As a member of our professional staff cohort, you will be actively involved in working towards our vision of a better world. By supporting the academic endeavour across teaching, research, and the student life, you’ll have the opportunity to contribute to activities that have a lasting impact on our community.

Join a community where excellence is at the core of our culture, contributions are valued and a range of benefits and rewards are available, such as:

• 26 weeks paid parental leave or 14 weeks paid primary caregiver leave
• 17% superannuation contributions
• 17.5% annual leave loading
• Access to flexible working arrangements
• Health and wellness discounts – fitness passport access, free yearly flu vaccinations, discounted health insurance, and access to our Employee Assistance Program for staff and their immediate family
• On campus childcare options
• Cheap parking (from just $5.75 a day)
• Salary packaging options

About This Opportunity 

As the Quality Control Lead at BASE Clinical, you will be responsible for setting up QC laboratories for clinically-enabling Phase I mRNA materials and lipid nanoparticle formulations (LNP), and ensure the strategic goals of the facility are met. You will help deliver on equipment procurement, analytical assay development and qualification, and writing technical documents. You will oversee all aspects of the BASE Clinical’s QC function in compliance with the facility Quality Management System and meeting relevant regulatory standards to meet Phase I clinical manufacture.

Key responsibilities will include: 

• Leadership: Exercise ‘Supervisor’ level leadership and management responsibility in accordance with the UQ Leadership Framework. Build and lead a QC unit responsible for setting up and operation of QC laboratories. Supervise QC scientists as the team grows by leading and motivating staff members in achieving organisational goals.
• Set up and operate QC unit: Lead equipment procurement and analytical assay development and qualification, including SOP development and deployment. Handle the day-to-day operations of QC laboratories under a quality management system (QMS). This includes directing the planning, implementation, and execution around QC testing of mRNA and LNP formulations, operating QC equipment, and performing QC analytics according to the protocol, timelines and KPIs.
• QC systems: Manage and lead QC systems and procedures for testing and releasing of phase-appropriate clinical mRNA materials. Manage all QC test procedures including environmental monitoring. Approve specifications, sample management, analytical test methods and other procedures related to QC.
• Equipment Management and Maintenance: Oversee the qualification, operation, and maintenance of QC equipment, and coordinate repairs and calibrations.
• Compliance and Documentation: Maintain, monitor, and document accurate records of QC data in compliance with the facility QMS.
• Safety Management: Uphold a safe working environment by enforcing safety protocols and conducting regular safety audits. Address any safety concerns promptly and effectively.
• Inventory Management: Monitor and manage inventory levels of consumables and equipment. Manage budgeting and ensure the timely availability of necessary materials.
• Collaboration: Work closely with other BASE Clinical departments, such as R&D, Production, Quality Assurance, Projects, Support and Leadership, to ensure optimal performance and address cross-functional issues. Maintain collaborative working relationship with external clients to meet project timelines.
• Reporting: Prepare and present regular reports on QC performance, challenges, and progress. Write, review, and approve protocols and reports.
• Client facing duties: Act as the primary client-facing QC technical liaison to understand their needs, address concerns and drive collaborative solutions for successful project execution.

This role is subject to The University’s Code of Conduct .

This is a full-time (100%), fixed-term position for up to 2 years.

At HEW level 8, the full-time equivalent base salary will be in the range $108,975.08 - $122,176.31, plus a generous super allowance of up to 17%. The total FTE package will be up to $127,500.84  - $142,946.29 annually. As this role is covered by an Enterprise Agreement, you will also receive regular remuneration increases – at least once a year.

About You  

• Postgraduate qualifications in Biotechnology, Bioengineering, Pharmaceutical Sciences, or related field or combination of relevant industry and management experience.
• Minimum of 5 years of experience in a similar operations role under a QMS and with team leadership experience, preferably in the pharmaceutical or biotechnology industry in QC testing roles.
• Practical experience of analytical sciences and technologies, analytical method development and qualification, QC testing and release of clinical materials for clinical trials.
• Prior experience in mRNA and LNP formulations preferred.
• Strong leadership and team management skills with experience mentoring team members. Experience building and leading teams and in establishing and monitoring departmental goals and metrics.
• Excellent problem-solving and analytical abilities.
• Technical writing skills and proficiency in investigations and root cause analysis.
• Deep understanding of quality governance and working in a regulated environment or working under a QMS.  Familiarity with regulatory requirements in pharmaceutical manufacturing (e.g., TGA cGMP, PIC/S) preferred.
• Proven ability to assess risk, collaborate with support groups to develop suitable action plans, and minimise potential impact.
• Strong communication and interpersonal skills with the ability to communicate with clarity across all functional groups and levels of the organisation.
• Ability to multitask and be agile in a fast-paced and dynamic, cross-functional environment.
• Employ strong analytical and problem-solving skills to manage shifting priorities, demands and timelines.

In addition, the following mandatory requirements apply:

• Work Rights: You must have unrestricted work rights in Australia for the duration of this appointment to apply. Visa sponsorship is not available for this appointment. 
• Background Checks: All final applicants for this position may be asked to consent to a criminal record check. Please note that people with criminal records are not automatically barred from applying for this position. Each application will be considered on its merits. 

For more information about this opportunity, please contact Rachel Chang - [email protected]

For application queries, please contact [email protected] stating the job reference number (below) in the subject line. 
 

All applicants must upload the following documents in order for your application to be considered:

• Cover letter addressing the ‘About You’ section  
• Resume 
   

At UQ we know that our greatest strengths come from our diverse mix of colleagues, this is reflected in our ongoing commitment to creating an environment focused on equity, diversity and inclusion .  We ensure that we are always attracting, retaining and promoting colleagues who are representative of the diversity in the broader community, whether that be gender identity , LGBTQIA+ , cultural and/or linguistic , Aboriginal and/or Torres Strait Islander peoples , or people with a disability . Accessibility requirements and/or adjustments can be directed to [email protected] .

If you are a current employee (including casual staff and HDR scholars) or hold an unpaid/affiliate appointment, please login to your staff Workday account and visit the internal careers board to apply for this opportunity. Please do NOT apply via the external job board.

Applications close 11 April 2024 at 11.00pm AEST (Job Reference Number – R-36953). Please note that interviews have been tentatively scheduled for April.